BPD-DS & Sleeve Gastrectomy Journal Club

1. BPD-DS & Sleeve Gastrectomy Journal Club Goal: To review 4 important and clinically relevant papers from 2010 on BPD-DS or Sleeve Gastrectomy 4 papers; x4 min each

2. Article #1 British Journal of Surgery 2010;97(2):160-166

3. Background • Long-term follow-up studies of super-obese patients (BMI >50) have shown high weight loss failure rates following RYGB. • Lap. BPD with duodenal switch (LDS): • Surgical option for super-obesity • But …. technically more complex & higher nutritional complications • Operative safety, weight loss and long-term complications of the two procedures have not been evaluated in a randomized trial.

4. Aim • To conduct a prospective, 2-centre randomized trial, comparing LRYGB vs. LDS for super-obese patients Endpoints • Primary: Weight loss (at 1 yr) • Secondary: Early (< 30 days) & late (up to 1 yr) complications, changes in body composition, co-morbidities, nutritional status & quality of life

5. Methods • 2 centers, equally high volume units: • Oslo University Hospital • Sahlgrenska University Hospital, Gothenburg • Inclusion criteria: • BMI 50-60 kg/m2, Age 20-50 years • Exclusion criteria • Previous bariatric or major abdominal surgery • Severe cardiopulmonary disease, malignancy, steroids, substance abuse or psych. illness • All patients underwent same pre-op preparation incl. 1000 kcal/day diet x3 weeks. Same peri-op routine for all (anesthesia, analgesia, fluid management)

6. Methods • Patients randomized to LRYGB or LDS (stratified acc to surgical centre, sex, age & BMI) • Results of randomization known only doctors enrolling patients, and schedulers. Patients informed 1 wk prior to procedure • LRYGB: linear staplers, 25 ml pouch, antecolic antegastric gastrojejunostomy, 150cm alimentary limb • LDS: Sleeve gastrectomy (30-32F), duodenum transected 4cm distal to pylorus, 200cm alimentary limb, 100cm common channel • Post-op follow-up with surgeon & dietician: • 6 weeks, 6 months, 1 year • LRGYB patients prescribed additional vitamin B12

7. Results CONSORT diagram

8. Results

9. Results Peri-operative results (<30 days) • No mortality • Mean (SD) operative time: • LRYGB: 91 (33) min • LDS: 206 (47) min ….. (p<0.001) • Conversion rates: 1 LDS procedure, 0 LRYGB • Complications: • LRYGB n=4 • LDS n=7 .…. (p=0.327) • Median (range) LOS • LRYGB 2 (2-15) days • LDS 4 (2-43) days .…. (p<0.001)

10. Results

11. Results • Late complications: • LRYGB: n=4 • LDS: n=9 ….. p=0.121 • Severe metabolic effects: • LRYGB: n=0 • LDS: n=2 (Hypoalbuminemia, iron def)

12. Results • Weight loss:

13. Discussion • Inexperience with procedure • High complication rate with bypass • Long term follow up

14. Conclusion Large difference in BMI at 1 year (6 kg/m2 lower in LDS group), and stability of weight loss after DS shown by other groups, suggest that LDS is better at promoting short- and long-term weight loss in super-obese patients

15. Article #2 Biertho et al, SOARD 2010;6(5):508-514

16. Background • Of all bariatric procedures, DS known to offer some of the best long-term weight loss results • Usually reserved for super-obese (BMI >50) because of increased risk of nutritional complications • Safety and efficacy of DS in patients with BMI<50 have not been well established …… as a primary procedure, or a secondary procedure in patients who have reduced their BMI to <50

17. To determine safety & efficacy of DS as a primary weight loss procedure in patients with BMI < 50 kg/m2 Aim

18. Methods • 810 consecutive patients, all with BMI <50 kg/m2, underwent DS at single institution from June 1992 to May 2005 • All procedures performed open • 250-cm3 sleeve gastrectomy created • Duodenum transected about 4 cm distal to the pylorus and anastomosed to a 250-cm alimentary limb, with a 100-cm common channel. • Routine cholecystectomy and appendectomy

19. Methods • Follow-up: • Patients usually seen at 3, 6, 9, and 12 months postoperatively. Thereafter, annual review (clinical & biochemical data collected) • Determined patient satisfaction every 5 years via mailed questionnaire

20. Results • 810 consecutive patients • 637 women (78.6%) • Mean age: 41.1 years • Mean preop BMI: 44.2 kg/m2 (Range 33-49) • Comorbidities: • DM 28% (n=227) • Hypertension 37% • Sleep apnea 25% • Mean follow-up: 103 months (Range 36-201) • Mean hospital stay: 6.9±5.4 days

21. Results Complications: • Intra-op: 0.7% (n=7) • Liver laceration (1) • Splenic injuries (6) • Major post-op: 4.9% (n=40) • 5 operative deaths (<30 days) • Minor complications: 8% (n=66) • Wound infections • Resp infections • Intestinal disturbance * * * *

22. Results Long-term outcomes Weight loss: • At mean of 8.6 years: • EWL 76% ± 22.3% • Only 11% had EWL <50% • BMI was <35 in 92%, and < 30 in 71%

23. Results • Comorbidity status postoperatively: • DM: 92.5% ‘cured’ (requiring no medications) • Hypertension: 60% no longer requiring anti-hypertensives • Sleep apnea: Only 2% still require an apparatus • Patient satisfaction 63% very satisfied with weight loss 91% very satisfied with overall outcome

24. Results • Long-term complications • Rehospitalization required in 15.8% (n=127)

25. Results • Long-term complications • Nutritional status • Albumin: ↓ significantly postop • (41.6mg/dL preop to 40.7 mg/dL postop, p<0.001) • Severe hypoalbuminemia (<30mg/dL): 0.6% preop and in 1.1% postop (p=0.5) • Anemia: more prevalent postoperatively • 0.1% vs. 1.6%, p=0.006 • Vitamin A and Calcium deficiencies also more prevalent postoperatively (p=0.04 and p=0.0009, respectively) • Long-term mortality rate 3% (n=25) • 2 deaths related to bariatric surgery …. One at 18 months (malnutrition), another 3 years post DS (intestinal obstruction)

26. Discussion • Significant decreases in albumin, hemoglobin, folic acid, B12 calcium • Complication rate is significant • Why < 5% of surgeries

27. Conclusion DS is highly efficient in terms of weight loss in non super-obese patients, bringing great satisfaction to patients Long-term risks of malnutrition and nutritional deficiencies exist, but are usually manageable with medical treatment & only seldom require reoperation

28. Article #3 Annals of Surgery 2010;252(2):319-324 10/22/2014 Ann of Surg, 248, 5, Nov 08 28

29. Study Overview • Laparoscopic sleeve gastrectomy (LSG) was originally intended as a bridging procedure for super obese patients awaiting definitive bariatric intervention. • After early promising results, sleeve gastrectomy was proposed as a potential definitive treatment for morbid obesity • Long-term efficacy of LSG remains to be determined

30. Aim • To determine mid- and long-term efficacy (6 years results), and possible side effects of LSG as a treatment for morbid obesity

31. Methods • 53 patients underwent LSG between Nov 2001 & Oct 2002 • Inclusion criteria: • NIH guidelines for bariatric surgery • Restrictive procedure chosen according to an institutional algorithm1 • Follow-up: • Regular follow-up until 3 years postoperatively • Telephone questionnaire administered on 6th postop year • LSG procedure: • 34 F bougie, antrum spared 1 Cadière GB et al. Atlas of Laparoscopic Obesity Surgery 2007.

32. Outcomes measured: Weight loss (change in BMI and %EWL) Adverse events Quality of Life (determined using BAROS score^) Methods ^ Bariatric Analysis And Reporting Outcome System score

33. Results • Patient characteristics • Complete 6 yr data available in 78% (n=41) • 73% female, median age 44 years (Range 28-71) • Median preop BMI 39.0 kg/m2 (31-57) • Comorbidities: • 1 patient with DM • 5 with hypertension • 1 patient with GERD • 11 of the 41 patients underwent a 2nd stage DS for weight regain, between 3-6 yrs post LSG. • 2 other patients underwent a ‘re-sleeve’ operation Subgroup analysis performed

34. Results Efficacy • EWL at 3 years 72.8%, and at 6 years 57.3%

35. Results

36. Results • Comorbidity status • The single diabetic pt had resolution of the disease • Hypertension resolved in 2 of 5 • Quality of life • 43.4% (23 of original 53 patients) were either lost to follow-up, refused to respond to questionnaire, or needed another procedure …. All were considered ‘dissatisfied’ with LSG • Median BAROS score after 6 yrs was 5 (range 2-9)

37. Results • Failure rate • Patients who did not achieve 50% EWL, & those 23 who were unavailable for follow-up or needed a 2nd operation, were considered failures. • At 3 yrs: 47% • At 6 yrs: 64% • Postoperative morbidity • Major: 12.2% (n=5) • Leak (2), stenosis (1), bleeding (1), incisional hernia (1) • GERD reported by 26% (overall group) at 6 yrs • No surgery related mortality • 1 death from colon ca 4 yrs post LSG

38. Discussion • Discussion about “neo fundus” and grehlin is interesting but speculative • Weight regain is actually under reported by ”intention to treat” definition

39. LSG is a safe, effective, and well accepted bariatric procedure But appears to be associated with weight regain, & quite often associated with GERD symptoms, in longer term follow-up Weight regain but not GERD may be managed by a completion DS procedure after LSG Conclusions

40. Article #4 Surgery 2010;147(5):664-669 10/22/2014 Ann of Surg, 248, 5, Nov 08 40

41. Study Overview • Laparoscopic sleeve gastrectomy (LSG) is emerging as a promising therapy for the treatment of obesity and T2DM • LSG has been shown to produce better weight loss than gastric banding, and seems to be less invasive than gastric bypass with comparative outcomes. Therefore, LSG has been proposed as the recommended bariatric procedure for lower BMIs • Mechanisms accounting for beneficial effects of LSG on glucose homeostasis are not well understood and remain speculative

42. Aims • To assess the efficacy of LSG for T2DM treatment in non-severely obese subjects with poorly controlled diabetes under current medical treatment

43. Methods • 20 Asians with T2DM underwent LSG • Female 70% • Mean preop BMI 31.0 (±2.9) kg/m2 • Mean age 46.3 (±8.0) years • Mean HbA1C 10.1 (±2.2) % • Inclusion criteria: • 30-60 years old • T2DM for 6 months, poorly controlled (A1C>7.5%) • BMI 25-35 kg/m2 • C-peptide >1ng/mL • No irreversible major organ damage related to DM

44. ∆ Insulin ∆ Glucose ….. at 30 min during OGTT Methods • Serial measurements of insulin secretion using OGTT; at 1, 4, 12, 26, 52 wks postop • Early insulin secretory response to a specific glycemic response was measured by the ‘insulinogenic index’ • Resolution of DM defined as: • Fasting glucose < 126mg/dL, & A1C<6.5% • Without use of oral hypoglycemics or insulin

45. Results • N=20 • All pts on multiple medications • 4 taking Insulin (20%) • Mean op time 127 min (75-140) • Mean LOS 2.1 days (1-5) • No major complications

46. Results

47. DM remission postop: 1 wk 0% 4 wks 20% 12 wks 30% 26 wks 40% 52 wks 50% Mean HbA1C reduction at 52 wks: 3.0% Results

48. Normal insulin peak at 30 min Results • Insulin secretionduring OGTT • Preop: typical delayed insulin secretion

49. ∆ Insulin ∆ Glucose ….. at 30 min during OGTT Results AUC(uIU.min/mL) • Preop 3,135 • 1 wk 2,989 • 4 wks 2,211 • 12 wks 1,584 • 26 wks 3,621 • 52 wks 3,351 Insulinogenic Index • Preop 0.02 • 1 wk 0.03 • 4 wks 0.04 • 12 wks 0.08 • 26 wks 0.2 • 52 wks 0.2 * * * * * * No significant difference compared to preop AUC * Significantly higher compared to preop index

50. C-peptide (ng/ml) ↓ postop Preop 3.3 1 wk 1.7 4 wks 2.1 12 wks 1.6 26 wks 2.0 52 wks 1.6 DM remission & C-peptide: C-peptide <3: 1/7 remitted C-peptide 3-6: 7/11 remitted C-peptide >6: 2/2 remitted …… p<0.05 Results